Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Know several methods of adapting a clinical trial and understand how they can be used.
Learn how to implement the adaptive design methods in available software.
Know some of the practical aspects of adaptive design implementation.
The course will focus on the practical implementation of the types of adaptive designs and will not go into deep statistical methodology. References will be provided to give the attendee links to the statistical formulae.
The following topics will be covered:
Dose escalation
Dose finding
Early stopping
Group sequential designs
Sample size re-estimation
Seamless phase II/III designs
Enrichment designs
Further practical issues including regulatory, data monitoring committees, data cleaning and randomisation systems
Registration costs (includes lunch and refreshments)
PSI are holding a limited number of hotel rooms until the 23rd October which will be allocated on a first come first served basis
Registration
PSI Members: £495 plus vat
Non-members: £570 plus vat (includes PSI membership for 1 year)
Academic Institution £295 plus vat
PSI are offering a multiple persons discount rate for multiple persons from the same company. £495 for the first delegate then £295 each for up to three more delegates.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK